Allied Rubber Industries Sdn. Bhd.
Malaysia(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 2
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Guardian & Janitex Condom/Prophylactic Ref K896098
Patient Examination Gloves Ref K892487
What Allied Rubber Industries Sdn. Bhd. makes
Allied Rubber Industries Sdn. Bhd. manufactures latex condoms and prophylactic devices under the Guardian and Janitex brands, as well as patient examination gloves. These products are designed for medical and personal protective use in clinical settings.
The company’s portfolio includes devices classified as Class I and Class II under regulatory frameworks, with relevant products listed via the FDA’s 510(k) pathway. The manufacturer operates from the US.
Frequently asked questions
What types of medical devices does Allied Rubber Industries Sdn. Bhd. manufacture?
Allied Rubber Industries Sdn. Bhd. specializes in latex-based medical devices, including condoms and prophylactic devices under the Guardian and Janitex brands, as well as patient examination gloves. These products are designed for clinical use to ensure protection and hygiene in medical settings.
Where is Allied Rubber Industries Sdn. Bhd. based?
The company operates from the United States, serving global markets with its medical and protective devices.
Which regulatory registries list devices manufactured by Allied Rubber Industries Sdn. Bhd.?
Relevant devices from Allied Rubber Industries Sdn. Bhd. are listed in the FDA’s 510(k) registry, which is a pathway for demonstrating substantial equivalence to predicate devices in the US.
How are the devices produced by Allied Rubber Industries Sdn. Bhd. classified under regulatory frameworks?
The company’s devices fall under Class I and Class II classifications, which determine the level of regulatory oversight required. Class I devices generally pose minimal risk, while Class II devices may require additional controls due to moderate risk.
Information
- Country
- Malaysia